Digital Tool for Psychological Support in Women With Breast Cancer
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Costa del Sol
About this trial
This study will design, test, and evaluate SerenApp, a digital health tool created to support women after completing treatment for breast cancer. Many women live for many years after breast cancer, but a large number continue to experience emotional difficulties such as anxiety, sadness, stress, or fear of the cancer coming back. These problems can strongly affect quality of life and are often not addressed during routine medical visits.
SerenApp is being developed as a safe, easy-to-use mobile application that provides psychological support and practical resources to help breast cancer survivors manage these challenges. What makes this project different is that the app will be created together with patients and healthcare professionals, to ensure that it responds to real needs and is adapted to the public health system in Spain.
The main questions of the study are:
Can SerenApp help women feel less anxious, depressed, or stressed and improve their overall quality of life?
Will women and professionals find the app useful, acceptable, and easy to use?
Could this digital tool reduce the need for additional healthcare resources and be cost-effective for the health system?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
SerenApp Digital Psychological Intervention
DeviceSerenApp is a co-created, personalized digital intervention designed to support the mental health of women in breast cancer follow-up or survivorship. The app includes modules targeting stress coping, anxiety, and depression, delivered via smartphone or computer. Content and functionalities were developed collaboratively with patients and healthcare professionals, ensuring usability, clinical relevance, and adherence to regulatory and ethical standards. The intervention is intended for self-guided use over eight weeks, with monitoring of engagement, completion, and user satisfaction.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: SerenApp InterventionExperimental treatment 1 intervention
Group B: Usual Oncological Follow-upNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Stress Coping Strategies
The CAEPO assesses cognitive and behavioral coping strategies used by oncology patients to manage stress related to their disease. It includes 40 items across seven subscales: Confrontation and Active Fighting, Self-Control and Emotional Control, Seeking Social Support, Anxiety and Anxious Worry, Passivity and Passive Resignation, Escape and Distancing, and Denial. Each item is rated on a 4-point Likert scale (0-3), with higher scores indicating greater use of each coping strategy.
Time frame
Baseline (T0) and 8 weeks (T1)2
Change in Anxiety Symptoms
Measured using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A), this outcome evaluates changes in anxiety symptom severity in breast cancer survivors. The HADS-A consists of 7 items rated on a 0-3 Likert scale, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptoms.
Time frame
Baseline (T0, before intervention) and 8 weeks post-intervention (T1)3
Change in Depressive Symptoms
Depressive symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item scale widely used in oncology and primary care. Higher scores indicate more severe depression. Total Score: 0-27
Time frame
Baseline (T0) and 8 weeks (T1).Secondary outcomes
1
Change in Health-Related Quality of Life
Measured with the EQ-5D-5L, a standardized instrument for assessing health status across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression Scale: Each of 5 dimensions rated from 1 (no problems) to 5 (extreme problems) Interpretation: Higher scores indicate better health-related quality of life (better outcome)
Time frame
Baseline (T0) and 8 weeks (T1)2
Usability of SerenApp
Measured with the System Usability Scale (SUS), a validated 10-item scale assessing usability and acceptability of digital interventions. Scale: 0-100 Interpretation: Higher scores indicate better usability and acceptability (better outcome)
Time frame
8 weeks (T1, post-intervention only).3
Satisfaction with Care
Measured with the Client Satisfaction Questionnaire-8 (CSQ-8), a validated tool assessing satisfaction with the intervention and overall care. Scale: 1-4 per item across 8 items Total Score: 8-32 Interpretation: Higher scores indicate greater satisfaction with care and the intervention (better outcome)
Time frame
8 weeks (T1)Other outcomes
1
Healthcare Resource Use and Cost-effectiveness
Resource use will be collected with the Client Service Receipt Inventory (CSRI), complemented with economic evaluation measures, to estimate cost-effectiveness of SerenApp compared to usual follow-up. Scale: Not standardized; costs reported in monetary units Interpretation: Lower costs with equivalent or improved outcomes indicate better cost-effectiveness
Time frame
Baseline (T0) and 8 weeks (T1)2
Adherence to the Intervention
Measured with the Mobile Application Rating Scale (MARS) and app usage metrics (logins, time spent, module completion rates). MARS Scale: Typically 1-5 per item Usage Metrics: Number of logins, time spent, module completion rates Interpretation: Higher scores and greater engagement indicate better adherence (better outcome)
Time frame
Continuously during the 8-week intervention period3
Qualitative Experiences, Barriers, and Facilitators
Explored through post-intervention focus groups with participants and healthcare professionals, analyzed using qualitative methods to identify barriers, facilitators, and perceived benefits. Scale: Not applicable (qualitative analysis) Interpretation: Themes are identified through focus group discussions; no numerical scoring
Time frame
After 8 weeks (T1)Sponsors and contacts
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Source ClinicalTrials.gov
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